FDA's counterfeit Ozempic alerts: three lots, what was found, how to check a pen

Three times since late 2023, FDA has announced that counterfeit Ozempic pens were found inside the legitimate US supply chain, meaning they reached wholesalers or pharmacies, not only grey-market websites. The alerts are short and specific. Here they are.

1. December 21, 2023

   Lot NAR0074, serial 430834149057

   FDA and the manufacturer seized thousands of units. FDA's analysis found the needles were counterfeit, so their sterility could not be confirmed, which FDA described as an increased risk of infection. The pen labels, information materials and cartons were also counterfeit. FDA said it was still analysing the drug content at the time of the alert.

2. April 14, 2025

   Lot PAR0362, serial number beginning 51746517

   Several hundred units seized. FDA said analysis of the contents was ongoing and advised against using any pen with that combination of lot and serial prefix.

3. December 5, 2025

   Lot PAR1229

   Dozens of units seized. FDA identified the counterfeits by differences on the label and said testing to determine composition and safety risks was under way.

How to check a pen against these alerts

1. Find the lot number and serial number on the pen label and carton. Genuine Ozempic prints both.
2. Compare against the three alerts above. Lot NAR0074 with serial 430834149057, lot PAR0362 with a serial beginning 51746517, and lot PAR1229 are the combinations FDA has published as counterfeit.
3. Look at the label quality, the needle packaging and the carton. FDA's alerts describe counterfeits identified by label differences and by counterfeit needles.
4. If in doubt, do not use it. Call the dispensing pharmacy; the manufacturer runs an authenticity line that FDA's alert pages reference.

Why this page is on a compounding site

Because "is it real" and "is it compounded" are two different questions that people run together. A counterfeit pen is a criminal product imitating the approved drug. A compounded vial is not imitating anything; it is a different, unapproved product made under a prescription, and its risks are the ones on the rest of this site: who made it, from what, under which section of the law. If someone offers you "Ozempic" in a vial, or pens at a price the manufacturer does not charge, you are looking at one of the two problems and should find out which. FDA's GLP-1 concerns page treats both.

Reporting

A suspected counterfeit goes to MedWatch and to the pharmacy that dispensed it. Include the lot, the serial, photographs of the pen and carton, and where you obtained it. If it came from a website rather than a pharmacy, include the URL.